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Pittsburgh, Pennsylvania 15213

  • Ischemia

Purpose:

The study objective is to examine the recanalization efficacy of the EmboTrap device and its associated performance characteristics and to record associated clinical outcomes in a manner that facilitates relevant comparison of outputs with that of devices approved in the U.S. for clearing Large Vessel Occlusions.


Criteria:

Inclusion Criteria: 1. The patient or the patient's legally authorized representative has signed and dated an Informed Consent Form. 2. Aged between 18 years and 85 years (inclusive). 3. A new focal disabling neurologic deficit consistent with acute cerebral ischemia. 4. NIHSS score ≥8 and ≤25. 5. Pre-ictal mRS score of 0 or 1. 6. The interventionalist estimates that at least one deployment of the EmboTrap device can be completed within 8 hours from the onset of symptoms. 7. Patients for whom IV-tPA is indicated and who are available for treatment, are treated with IV-tPA. 8. IV-tPA, if used, was initiated within 3 hrs of stroke onset (onset time is defined as the last time when the patient was witnessed to be at baseline), with investigator verification that the subject has received/is receiving the correct IV t-PA dose for the estimated weight. 9. Angiographic confirmation of an occlusion of an ICA (including T or L occlusions), M1 or M2 MCA, VA, or BA with mTICI flow of 0 - 1. 10. For strokes in the anterior circulation the following imaging criteria should also be met: 1. MRI criterion: volume of diffusion restriction visually assessed ≤50 mL. OR 2. CT criterion: ASPECTS 6 to 10 on baseline CT or CTA-source images, or, volume of significantly lowered CBV ≤50 mL. 11. The patient is indicated for neurothrombectomy treatment by the interventionalist and it is confirmed by diagnostic angiography that the device will be able to reach the target lesion proximally. Exclusion Criteria: 1. Life expectancy likely less than 6 months. 2. Females who are pregnant or breastfeeding. 3. History of severe allergy to contrast medium. 4. Known nickel allergy at time of treatment. 5. Known current use of cocaine at time of treatment. 6. Patient has suffered a stroke in the past 3 months. 7. The patient presents with an NIHSS score <8 or >25 or is physician assessed as being in a clinically relevant uninterrupted coma. 8. Subject participating in another study involving an investigational device or drug. 9. Use of warfarin anticoagulation or any Novel Anticoagulant with International Normalized Ratio (INR) >3.0. 10. Platelet count <50,000/μL. 11. Glucose <50 mg/dL. 12. Any known hemorrhagic or coagulation deficiency. 13. Unstable renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30. 14. Patients who have received a direct thrombin inhibitor within the last 48 hours; must have a partial thromboplastin time (PTT) less than 1.5 times the normal to be eligible. 15. All patients with severe hypertension on presentation (SBP> 220mmHg and/or DBP>120mmHg). All patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous therapy (SBP >185mmHg and/or DBP>110mmHg). . 16. Known cerebral vasculitis. 17. Rapidly improving neurological status. 18. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories. 19. Ongoing seizure due to stroke. 20. Evidence of active systemic infection. 21. Known cancer with metastases. 22. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation. 23. Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma). 24. Suspicion of aortic dissection, presumed septic embolus, or suspicion of bacterial endocarditis. 25. Stenosis, or any occlusion, in a proximal vessel that requires treatment or prevents access to the site of occlusion. 26. Evidence of dissection in the extra or intracranial cerebral arteries. 27. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).


Study is Available At:


Original ID:

CIP002


NCT ID:

NCT02488915


Secondary ID:


Study Acronym:

ARISEII


Brief Title:

Analysis of Revascularization in Ischemic Stroke With EmboTrap


Official Title:

ARISE II (Analysis of Revascularization in Ischemic Stroke With EmboTrap) Study


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Neuravi Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

228


Enrollment Type:

Actual


Overall Contact Information

Official Name:Prof. Sam Zaidat, M.D.
Principal Investigator
St. Vincent Mercy Mercy Hospital, Toledo,Ohio, USA

Study Dates

Start Date:November 2015
Completion Date:September 2017
Completion Type:Actual
Primary Completion Date:May 2017
Primary Completion Type:Actual
Verification Date:June 2018
Last Changed Date:June 13, 2018
First Received Date:June 30, 2015
First Results Date:May 17, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating)
Time Frame:Post-treatment
Safety Issues:False
Description:Successful achievement of the endpoint is defined as achieving an mTICI score of 2b or greater in the target vessel following 3 or less passes of the EmboTrap device. Patients treated with rescue prior to completion of three passes with EmboTrap were trea
Outcome Type:Primary Outcome
Measure:Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) Within 24 Hours Post-procedure and Any Other Serious Adverse Device Effects (SADE)
Time Frame:24(-8/+12 hrs) hours post-procedure and 90(±14) days Post Procedure
Safety Issues:False
Description:The primary safety endpoint will be measured as the occurrence of Symptomatic Intracerebral hemorrhage (sICH) within 24 hours (-8/+12 hrs) post-procedure, together with any other Serious Adverse Device Effects (excluding those already counted in sICH). s
Outcome Type:Secondary Outcome
Measure:Good Clinical Outcome as Defined by Modified Rankin Scale (mRS) Score ≤2
Time Frame:90(±14) days Post Procedure
Safety Issues:False
Description:Good Clinical Outcome is defined as achieving an mRS score of ≤2 at 90 days post procedure. mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological d
Outcome Type:Secondary Outcome
Measure:Procedure Time
Time Frame:Post-treatment
Safety Issues:False
Description:The time from groin puncture to achievement of mTICI ≥2b, or if not obtained, to the final angiogram. mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion mTICI 1 = Penetrat
Outcome Type:Secondary Outcome
Measure:All Procedure-related Mortality
Time Frame:Day 7 post-procedure
Safety Issues:False
Description:Any death that is deemed to have been caused by the study procedure.
Outcome Type:Secondary Outcome
Measure:All-cause Mortality
Time Frame:90(±14) days Post Procedure
Safety Issues:False
Description:Any death that occurs within 90(±14) days post-procedure.
Outcome Type:Secondary Outcome
Measure:Occurrence of Serious Adverse Device Effects (SADE)
Time Frame:90(±14) days Post Procedure
Safety Issues:False
Description:SADE was categorized as any serious adverse event that was deemed to be caused by the study device.
Outcome Type:Secondary Outcome
Measure:Occurrence of Procedure Related Serious Adverse Events (PRSAE)
Time Frame:90(±14) days Post Procedure
Safety Issues:False
Description:PRSAE was categorized as any serious adverse event that was deemed to be caused by the study procedure.
Outcome Type:Secondary Outcome
Measure:Occurrence of Symptomatic Intracerebral Hemorrhage (sICH)
Time Frame:24(-8/+12) hours post-procedure
Safety Issues:False
Description:sICH was assessed using the Heidelberg Bleeding Classification, i.e. any intracerebral hemorrhage associated with an increase of ≥4 points in the NIHSS scale or an increase of ≥2 points of a NIHSS subcategory or that leads to major medical intervention.
Outcome Type:Secondary Outcome
Measure:Occurrence of Neurological Deterioration
Time Frame:24(-8/+12) hours post-procedure
Safety Issues:False
Description:An increase of 4 points or more on the National Institutes of Health Stroke Scale (NIHSS) at 24 hours (-8/+12 hrs) post-procedure. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the l
Outcome Type:Secondary Outcome
Measure:Proportion of Subjects With Evidence of Infarction of a Previously Uninvolved Vascular Territory
Time Frame:24(-8/+12) hours post-procedure
Safety Issues:False
Description:Infarction (i.e. brain tissue death) of a previously uninvolved vascular territory (i.e. region of the brain) is evaluated from 24-hour imaging (Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)).
Outcome Type:Secondary Outcome
Measure:Time to Treat
Time Frame:Post-treatment
Safety Issues:False
Description:The time from first baseline angiogram to achievement of mTICI ≥2b, or if not obtained, to the final angiogram. mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion mTICI 1

Study Interventions

Intervention Type:Device
Name:EmboTrap® Revascularization Device
Arm Name:EmboTrap® Revascularization Device
Other Name:EmboTrap II

Study Arms

Study Arm Type:Experimental
Arm Name:EmboTrap® Revascularization Device
Description:Mechanical Thrombectomy with EmboTrap

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Neuravi Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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